Lens Exchange Sytem
Lens Exchange System LES G23 three unit package
1manufacturer
2catalogue numbers in this listing
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
Record
| Listed by | Visioncare Ophthalmic Technologies Ltd. |
|---|---|
| FDA product code | KYB |
| Device type | Lens, Guide, Intraocular |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4300 |
| Premarket notification | Exempt |
| Record published | 2017-06-01 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: • Do not store the device in direct sunlight; Storage environment temperature up to 43 °C; Storage environment humidity up to 95 % RH; Storage environment humidity from 20 % RH; Storage environment temperature from 10 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| G23 | 3 | In distribution | |
| G25 | 3 | In distribution |
Same Product Code
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|---|---|---|
| Duckworth & Kent | Duckworth AND Kent Limited | 5 |
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| Monarch® II | Alcon Laboratories, Inc. | 2 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 2 |
| Unfolder Silver | Johnson & Johnson Surgical Vision, Inc. | 2 |
| Monarch® III | Alcon Laboratories, Inc. | 2 |
| IOL Manipulator – Sinskey | Hurricane Medical | 2 |
| Viscoject 1.8 Injector Set | Medicel AG | 1 |
| Bausch + Lomb | Bausch & Lomb Incorporated | 1 |
| Nucleus Chopper – P. Koch | Hurricane Medical | 1 |
| Surgical Glide | Hurricane Medical | 1 |
| Unfolder Platinum 1 Series | Johnson & Johnson Surgical Vision, Inc. | 1 |
Showing 12 of 18. All products under Lens, Guide, Intraocular
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.